I. Field of Invention
The present invention relates to tampons, more specifically to an improved tampon assembly or tampon applicator incorporating indicators in the manufacture well known in the medical field for testing excreted biological fluids for comparison to accompanying diagnostic, color chart. Said indicators may also be applied, but not limited to, sanitary napkins, panty liners, incontinence diapers for babies and adults, bandages and the like that utilize the same or similar hydrophilic materials for absorbing biological fluids as that of a conventional tampon body.
II. Description of the Prior Art
Conventional tampons for absorbing catamenia, or impregnated with various spermicides, deodorants, etc. are well known in the art as are tampons utilized to carry medicaments into the vaginal cavity. However, a tampon for testing biological fluids which incorporate indicators such as, but not limited to litmus for determining pH balance and identifying other than normal bacterial activity in the biological fluid excreted from the vaginal cavity are virtually unknown in the art as described herein.
Tampons utilized to carry a medicament into the vaginal cavity are well known, and are illustrated, for example, in U.S. Pat. No. 4,309,997, issued Jan. 12, 1982; and U.S. Pat. No. 4,318,405 and various other patents described therein. All tampons have in common the use of an absorbent material, generally referred to as hydrophilic. In addition to aforementioned patents, hydrophilic materials are described in, inter alia, U.S. Pat. No. 4,475,911, issued Oct. 9, 1984. As used herein, the term "absorbent" refers to materials which are hydrophilic as that term used in U.S. Pat. No. 4,475,911.
As the foregoing patents demonstrate, it is well known to use various "medicaments," which, as used herein, includes materials such as deodorants and the like as well as material whose use is more generally considered to be for therapeutic purposes. Medicaments may be used seriatim in conjunction with tampons, that is, the medicament is inserted into the vaginal cavity, followed by the tampon to prevent leakage. Such a seriatim procedure has numerous obvious disadvantages. Attempts to avoid these disadvantages generally fall into two categories, either the tampon is impregnated with the medicament, such as is described in U.S. Pat. No. 4,309,997, or the medicament is carried in encapsulated form by the tampon, as is described in U.S. Pat. No. 4,318,405. Devices of the type described in U.S. Pat. No. 4,309,997 present problems related to the shelf life of the medicament, allergic reactions to the type of medicament used, and the inconvenience of pre-wetting the tampon, which is often required. Tampons of the type described in U.S. Pat. No. 4,318,405 retain the encapsulated medicament in the tampon both before and after insertion of the tampon into the vaginal cavity, and so may suffer from many of the same disadvantages as the impregnated tampons. In addition, upon dissolving of the encapsulated medicament, much of the medicament will be absorbed by the tampon itself, rather than being applied directly to the body surfaces. Because of the relatively small volume of medicament carried in such a device, often the medicament fails to reach the affected area in sufficient strength. There is also a possibility that the vaginal cavity may be lacking in a sufficient amount of body fluid to dissolve the capsule and ensure medicament application.
Insofar, the prior art which incorporates use of medicaments do not identify or make known a process for identifying whether or not bacterial condition of the vaginal cavity is conducive to introduction of such medicaments, therapeutic or contraceptive. Within this description of the prior art, reference to indicators identifying pH levels are intended as an example for illustrative purposes but not for its use to be limited by such example.
Extensive research in the field of Gynecology confirms that the vaginal cavity contains numerous naturally occurring bacterial flora which are very sensitive to the introduction of medicaments. The condition of the flora is generally identified by toxicity and can be measured via a pH test process well known in the medical field. As previously mentioned, a tampon or other hydrophilic material utilized for absorbing and testing of biological fluids incorporating in the manufacture an indicator such as litmus, for determining pH balance of biological fluid excreted from the vaginal cavity or such as keytone for testing excretions from the adjacent urethral opening are currently unknown in the art. This example of an indicator applied to test pH generally uses, but is not limited to litmus, also known as turnsole or lacmus, which contain litmus, a natural pigment obtained from lichens whose main principle is azolitmin manufactured primarily in a paperlike form whereby color-indicators range from acidic pH colored red (below 4.5) to alkaline pH colored blue (above 8.3). Azolitmin is a brownish-red coloring principle found in cudbear and other commercial litmus preparations for testing. Cudbear is a dusky-red-purple to very dusky red powder obtained from species of Rocella de Candolle, Lecanora Archius or other lichens. Amaranth is another commonly used herb that is a red azo dye used in place of cudbear preparations. There are no known toxic exposures to the agents constituent in litmus, its variations or principle components. Rather, litmus detects toxicity variations present in biological fluids indicative of other than normal conditions. Normal pH levels within the vaginal cavity range approximately from 3.8-4.2. When the vaginal pH is 5.0 or greater, levels indicate vaginosis or atrophic vaginal discharge as described in Principles and Practice of Clinical Gynecology, p. 598. Utilizing such tests provides a means for early detection of harmful bacterial activity which cause infections that could be identified via corresponding pH levels at an early and treatable stage. Due to the nature of the indicator, application is not harmful to the user nor is it chemically reactive to present medicaments.
The only relevant prior art discovered is identified in an article referencing tests conducted at the University of Athens entitled "Evaluation of Lactate Dehydrogenase Activity as an Index of Cervical Malignancy" (European Journal of Gynaecology Oncology, 12(6) 471-6 1991); presents a tampon known as Gynaegnost coated with chemical compounds PMS (phenazin methosulfate) basically an electron conductor which draws NADH (biological fluid) to the surface cover of the tampon coated with NBT (nitrobluetetrazolium-chloride), a coloring agent which becomes blue (diformizan) in the presence of LDH (lactose dehydrogenase) activity. Intensity of the diformizan coloration corresponds to the intensity of the LDH activity. Several disadvantages are apparent with this method:
a. A lay user could conduct this test outside a laboratory setting, however, results are intended to identify preinvasive or invasive cervical malignancy which is a very serious disorder to have a lay user diagnose particularly with one coloring agent and chemical compounds that should be used under the supervison of a gynelogical authority. PA1 b. While Gynaegnost tests for cervical cancer (CaCx), the test results have concluded with many false positive readings which distorts the accuracy and validity of the test. PA1 c. Further notations in the journal specifically state that the test should not be conducted in the presence of vaginitis or cervicitus due to the occurrence of the false positive disqualification. PA1 a. Indicators are available in various material forms such as paper strips, dyes, pastes and the like with varying degrees of color spectrums that can be incorporated in accordance with the manufacture of a tampon assembly, wholly or in parts. PA1 b. The nature of such indicators provides a very safe means of testing that will avoid inflicting harm on the user and is characteristically not chemically-reactive with existing medicaments. PA1 c. The tampon assembly or tampon applicator for delivery with indicators combined provides a test system that is versatile, simple, user-friendly, easy to read and easy to dispose of. PA1 d. False-positive distortion is less likely to occur as indicators are not adversely affected in the presence of infection but rather indicative of the infection. PA1 e. Indicators can be applied to any embodiment utilizing hydrophilic material for absorbing excreted biological fluid as the material which absorbs the fluid is a biological sample sufficient for testing. PA1 f. When indicators are used in conjunction with a tampon applicator for delivery of a medicament, the presence of such indicators will not hinder the application of medicaments but instead would enable testing the effectiveness of said medicaments post-application. PA1 g. The improved rounded front end of tampon applicator for delivery of a medicament would allow for easier insertion of the tampon applicator and make the removable closure more accessible and therefore easier to remove before use. PA1 h. The tampon applicator for delivery of a medicament is further improved by a dual-member telescopic ejection wand means with dosage measurement scale to provide a more efficient and accurate means of medicament application to ensure user applies the proper dosage in accordance with prescribed quantities whereby the dual-member wand precipitates easier handling of the medicament to be applied. PA1 i. The improved dual-member telescoping wand with dosage measurement scale allows medicament to be selectively pre-package or separately package a wider variety of medicaments such those of a lesser density for example, liquids which could prematurely activate collapse of the hollowed bore. This method of selective packaging provides for a more sanitary system of medicament application and prevent exposure of said medicaments to bacteria present in the environment. Further, this improvement would serve to minimize waste even further than is already available.
In contrast, the preferred embodiment of the present invention eliminates such unknowns by simply using the indicator to test the biological fluid and provide a quantitative analysis whereby coloration relates directly to a numerical level of intensity (acid or alkaline) with a corresponding prognosis chart indexed according to infection type that is generally accepted by gynecology professionals for which charts can be amended accordingly with continuous improvement of gynecology standards. As notated, Gynaegnost is not recommended for use during the presence of infection, whereas the present invention conversely encourages use of indicator testing pH balance of biological fluids to identify an impending infection for purposes of preventing progression of a simple infection to cervical malignancy.
The present invention not only utilizes the indicator as a pH test system for other than normal conditions of the vaginal cavity but further for tracking daily pH balance for purposes of natural contraception. There exists in the prior art many patents for tampons previously mentioned which include contraceptives as a form of medicament, in the manufacture. There does not appear to be any known prior art that utilizes the tampon assembly incorporating indicators for contraceptive purposes by determining whether chemical balance is conducive to conception which can therefore be avoided if the user so chooses.